drugset / Trial / NCT01893866
A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects
RandomizedCrossoverOpen-labelBasic science
Summary
The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant administered as two separate 1 mL injections and to characterize the pharmacokinetics of the new 30 mg strength.
Timeline
- Start
- 2013-08
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegvisomant | Protein / enzyme biologic | 15 mg | Subcutaneous |
| Subject | Pegvisomant | Protein / enzyme biologic | 30 mg | Subcutaneous |
Indications
No indication recorded.